NICE issues thumbs up for Basilea’s Toctino on the NHS

Shares in Swiss biotechnology group Basilea were given a boost last week after the National Institute for Health and Clinical Excellence published a Final Appraisal Determination recommending Toctino as a treatment for eczema.

Specifically, the cost watchdog for England and Wales has approved the use of Toctino (alitretinoin) on the National Health Service for adults with severe chronic hand eczema – classed by a physician's global assessment and a dermatology life quality index score of 15 or more - who have failed to respond to therapy with topical corticosteroids.

The move comes after a thorough cost analysis by the Institute concluded that, taking into account Toctino’s efficacy and price - £411.43 for a pack of 30 × 30mg capsules (excluding VAT) - the cost per QALY (quality per life year gained) is well below its threshold and the therapy is a cost-effective use of NHS resources.

Hand eczema is a common inflammatory skin disease thought to affect up to 10% of the general population, of which around 5%-7% suffer from the more severe, chronic form, which can impair the use of hands and therefore the performance of many everyday activities.

Toctino, a derivative of retinoic acid, is currently the only other approved option for patients with the condition who are unresponsive to topical corticosteroids. Both its approval by healthcare regulators and the endorsement by NICE is based on impressive data from a multinational multi-national Phase III programme, with one trial showing that the agent induced clear or almost clear skin in 47.7% of patients taking the drug compared to 16.6% in the placebo group.

Well-tolerated, but birth defects riskClinical trials also demonstrated that the agent is well-tolerated, with headache, dry mouth and anaemia amongst the most frequent side effects. However Toctino can cause birth defects if pregnant women are exposed to the drug, and so is contraindicated in those of childbearing age unless conditions of the Pregnancy Prevention Programme are adhered to.

Dr Anthony Man, Chief Executive Officer, Basilea Pharmaceutica Ltd, said the positive FAD issued by NICE is “an important milestone” for the company, and that it offers patients who suffer from severe chronic hand eczema “a real chance to obtain hands cleared of eczema and the possibility to resume normal activities”.

The Scottish Medicines Consortium issued a stamp of approval for the drug’s use on the NHS in Scotland earlier this year.